U.S. patent application number 11/630895 was filed with the patent office on 2008-05-22 for nasal dilator and uses thereof.
Invention is credited to Alexandre Yazdi.
Application Number | 20080119885 11/630895 |
Document ID | / |
Family ID | 34947396 |
Filed Date | 2008-05-22 |
United States Patent
Application |
20080119885 |
Kind Code |
A1 |
Yazdi; Alexandre |
May 22, 2008 |
Nasal Dilator And Uses Thereof
Abstract
A mechanical nasal dilator includes a frame provided with
support plates (6,6') at its ends, the frame including a central
extranasal portion (1) and two intranasal portions (2,2'), wherein
the extranasal portion (2) of the frame is globally U-shaped,
whereof the central portion is elastic and spaces apart the nose
wings by spring effect, the end of each of the branches of the U
being itself U-shaped whereof one branch forms one part of the
extranasal portion of the frame and the other branch, located
between the branches of the extranasal portion of the frame, forms
the intranasal portions (2,2').
Inventors: |
Yazdi; Alexandre;
(Saint-Denis, FR) |
Correspondence
Address: |
YOUNG & THOMPSON
209 Madison Street, Suite 500
ALEXANDRIA
VA
22314
US
|
Family ID: |
34947396 |
Appl. No.: |
11/630895 |
Filed: |
June 28, 2005 |
PCT Filed: |
June 28, 2005 |
PCT NO: |
PCT/FR05/01634 |
371 Date: |
December 27, 2006 |
Current U.S.
Class: |
606/199 |
Current CPC
Class: |
A61F 5/08 20130101 |
Class at
Publication: |
606/199 |
International
Class: |
A61M 29/00 20060101
A61M029/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 28, 2004 |
FR |
0407085 |
Claims
1-10. (canceled)
11. A mechanical nasal dilator comprising a frame furnished with
pressure plates (6, 6') at its ends, the frame comprising a central
extranasal portion (1) and two intranasal portions (2, 2'),
characterized in that the extranasal portion (1) of the frame is
generally U-shaped, whereof the central portion is elastic and
parts the alas of the nose by spring effect, the end of each of the
branches of the U itself being U-shaped whereof one branch is a
portion of the extranasal portion of the frame and the other
branch, situated between the branches of the extranasal portion of
the frame, forms one of the aforementioned intranasal portions (2,
2').
12. The nasal dilator as claimed in claim 11, characterized in that
the length of an intranasal portion (2, 2') of the frame lies
between 0.5 and 1.5 cm.
13. The nasal dilator as claimed in claim 11, characterized in that
the pressure plates (6, 6') are installed at the end of the frame
between the U-shaped end branches.
14. The nasal dilator as claimed in claim 11, characterized in that
the pressure plates (6, 6') comprise a multidirectional pivot (5,
5') or are mounted on such a pivot.
15. The nasal dilator as claimed in claim 11, characterized in that
the multidirectional pivot (5, 5') is obtained thanks to a tapering
of the end of each of the branches of the U, directed toward the
outside of the extranasal portion (1) of the frame.
16. The nasal dilator as claimed in claim 11, characterized in that
the central extranasal portion (1) is doubly bent (3, 3')
symmetrically.
17. The nasal dilator as claimed in claim 16, characterized in that
each bend (3, 3') makes an angle lying between 75 and
165.degree..
18. The nasal dilator as claimed in claim 11, characterized in that
the frame is made of a flexible, shape-memory metal alloy such as
nickel-titanium or titanium-molybdenum.
19. The nasal dilator as claimed in claim 11, characterized in that
the frame is covered at least partly with a biocompatible material
such as a silicone or polyurethane.
20. The nasal dilator as claimed in claim 11, characterized in that
the pressure plates (6, 6') are arranged to deliver an active
ingredient associated or juxtaposed with said pressure plates
(6,6').
21. The nasal dilator as claimed in claim 12, characterized in that
the pressure plates (6, 6') are installed at the end of the frame
between the U-shaped end branches.
22. The nasal dilator as claimed in claim 12, characterized in that
the pressure plates (6, 6') comprise a multidirectional pivot (5,
5') or are mounted on such a pivot.
23. The nasal dilator as claimed in claim 13, characterized in that
the pressure plates (6, 6') comprise a multidirectional pivot (5,
5') or are mounted on such a pivot.
24. The nasal dilator as claimed in claim 12, characterized in that
the multidirectional pivot (5, 5') is obtained thanks to a tapering
of the end of each of the branches of the U, directed toward the
outside of the extranasal portion (1) of the frame.
25. The nasal dilator as claimed in claim 13, characterized in that
the multidirectional pivot (5, 5') is obtained thanks to a tapering
of the end of each of the branches of the U, directed toward the
outside of the extranasal portion (1) of the frame.
26. The nasal dilator as claimed in claim 14, characterized in that
the multidirectional pivot (5, 5') is obtained thanks to a tapering
of the end of each of the branches of the U, directed toward the
outside of the extranasal portion (1) of the frame.
Description
[0001] The present invention relates to a nasal dilator and its
applications.
[0002] Human nasal breathing (10 000 to 15 000 liters of air/day)
has essential functions, amongst others of warming and humidifying
the air, before it reaches the lungs. Its obstruction is therefore
harmful and uncomfortable, more particularly during sleep.
[0003] The partial or total closure of the nasal respiratory tract
may have different origins. Infectious and allergic
rhinosinusitises are the most frequent, on average two
episodes/year in adults. They form the most frequent medical
afflication, responsible for the highest rate of school and work
absenteeism with self-medication in 70% of patients. In the USA,
their cost is greater than 6 billion dollars per year. Chronic
rhinosinusitis (CRS) is the most frequent chronic illness; it
affects 1 individual in 6. CRS affects 75% of asthmatics and 50% of
people ill with CRS are asthmatics according to the National Center
for Health Statistics.
[0004] A breathing difficulty can also be observed in cases of
septum deviation, asthma, pregnancy and in children.
[0005] Sportsmen at full stretch also suffer from insufficient
nasal inspiration to satisfy their oxygen consumption. Snoring is
also a worrying symptom of breathing difficulty. Transitory or
constant mouth breathing is a symptom of insufficient nasal
breathing.
[0006] The chemical and surgical solutions and the devices that
exist on the market have major disadvantages. Frequent
prescriptions of antibiotics are controversial through their
absence of statistically significant advantages in the treatment of
presumed bacterial rhinosinusitis.
[0007] Sprays of vasoconstrictors and of corticosteroids cause a
secondary inflammation and are harmful to the nasal mucus;
secondary congestion encourages patients to continue the use of the
sprays with the risk of medicinal rhinitis and atrophy of the nasal
mucus. The sometimes essential surgical solutions are invasive,
like any surgical intervention, and costly. In addition they do not
always give the expected results.
[0008] Nasal dilators and nasal supports are a noninvasive
alternative to the chemical and surgical solutions.
[0009] Nasal supports as described for example in U.S. Pat. No.
5,922,006 or US-A-2002/0177871 do not part the nostrils and simply
prevent the collapse of the nasal partitions by supporting
them.
[0010] U.S. Pat. No. 1,034,123 describes a mechanical nasal dilator
comprising a frame consisting of an elastic cable whereof the
elasticity of the central extranasal portion pinches the top
portion of the nasal ridge situated between the eyes, then, based
on a loop which corresponds to the pinching point, comprises lower
branches which, on the contrary, part the nostrils. In other words,
one portion, the central portion, of the extranasal portion of the
frame pinches the nostrils while another portion, a lateral
portion, parts them. These lower branches comprise a frame extended
by an arc of a circle that only very slightly enters the nostrils
and comprises a pressure pad.
[0011] US 2002/000227 A and WO 00/66048 describe a mechanical nasal
dilator bonded to the outside of the nose. The former is totally
external to the nose and exerts its effect in the middle of the
nose, while the latter comprises a tongue that is slightly inserted
into the nose and, from a fixed point formed by the bonding of its
upper end, pulls the entrance of the nostrils forward.
[0012] The most common device currently is a mechanical nasal
dilator bonded to the outside of the nose comprising an extranasal
adhesive strip, bonded to the outside of the nostrils, marketed
under the name BreatheRight.RTM., which slightly increases the
nasal breathing flow. However, a bonded mechanical nasal dilator
like BreatheRight.RTM. cannot be reused; it does not bond to damp
or greasy skin. Made of latex, people allergic to latex cannot use
it. It is inconvenient for blowing the nose and it does not really
reduce snoring because it does not fulfill its first function of
sufficiently increasing the nasal breathing flow.
[0013] Another nasal dilator device is marketed under the name of
Nozovent.RTM.. It is a flexible device inserted into the nose that
parts the nostrils. Its "U" shape and the position of its frame
under the nose lead to a resultant of the exerted forces (the
parting force on the inner face of the side walls due to the
device, and the reaction of the side walls of the nostrils),
directed toward the outside of the nose. To remedy this and prevent
its spontaneous expulsion, Nozovent.RTM. is furnished with
protuberances on the end plates of the device to clamp the device
to the intranasal side walls of the nostrils. They may therefore be
a source of friction and irritation of the intranasal skin. The
device obstructs the entrance of the nostrils where touching
actions are frequent. This is why many users remove it
unconsciously during their sleep. In the event of an impact,
Nozovent.RTM. may be pushed far into the nostrils and therefore
presents a degree of risk.
[0014] It would therefore be desirable to have a practical and
effective nasal dilator that is simple to produce, well supported
and secure.
[0015] After lengthy research, the applicant has perfected such a
nasal dilator.
[0016] That is why the subject of the present application is a
mechanical nasal dilator comprising a frame furnished with pressure
plates at its ends, the frame comprising a central extranasal
portion and two intranasal portions, characterized in that the
extranasal portion of the frame is generally U-shaped, whereof the
central portion is elastic and parts the alas of the nose by spring
effect, the end of each of the branches of the U itself being
U-shaped whereof one branch is a portion of the extranasal portion
of the frame and the other branch, situated between the branches of
the extranasal portion of the frame, forms one of the
aforementioned intranasal portions.
[0017] In preferable conditions of embodiment of the invention, the
length of an intranasal portion of the frame lies between 0.5 and
1.5, preferably lying between 0.6 and 1.4, particularly lying
between 0.7 and 1.3, more particularly lying between 0.8 and 1.2
cm.
[0018] In yet other preferred conditions of embodiment of the
invention, the frame forms a continuous line formed of straight
line segments and curves, that includes no closed loop, and
particularly includes no angles, particularly acute angles.
[0019] In other preferred conditions of embodiment of the
invention, the frame is furnished with pressure plates at its ends.
The latter may be made in one piece with the frame. They are
preferably distinct pieces in the manner of most spectacle nose
plates. They are installed at the end of the frame between the
U-shaped end branches.
[0020] The pressure plates especially have the shape of a thin disk
6 to 10 mm in diameter and approximately 1 mm thick. Preferably
they have a convex shape in contact with the intranasal skin.
[0021] They are advantageously arranged, also like most spectacle
nose plates, in order to articulate freely to adapt to the
intranasal surface of the side walls of the nostrils and comprise
for this purpose advantageously a multidirectional pivot or are
mounted on such a pivot.
[0022] This articulation is advantageously obtained thanks to a
tapering of the end of each of the branches of the U, directed
toward the outside of the extranasal portion of the frame and
forming pivots. These tapers are then preferably arranged
approximately perpendicular to the intranasal branch. The
flexibility of the material at the location of the tapers is
sufficient to confer the desired freedom of articulation. A normal
device for spectacles may also be used such as a cup into which a
stud provided on the plates is inserted, said stud being furnished
with an eye traversed by a screw or similar element also passing
through the cup.
[0023] The length of an intranasal portion is advantageously such
that the pressure plates rest beyond the ostium internum.
[0024] In yet other preferred conditions of embodiment of the
invention, the central extranasal portion is doubly bent
symmetrically. Seen from the side, this central portion therefore
is generally chair-shaped.
[0025] In a preferred configuration, the angle thus formed is
preferably approximately 90.degree., like a chair, but may take
values lying between 45.degree.and 135.degree., preferably lying
between 57.degree. and 123.degree., particularly lying between
68.degree. and 112.degree., most particularly lying between
80.degree. and 100.degree..
[0026] In another preferred configuration, the angle thus formed is
preferably approximately 120.degree., like an easy chair, but may
take the values lying between 75.degree. and 165.degree.,
preferably lying between 87.degree. and 153.degree., particularly
lying between 98.degree. and 144.degree., most particularly lying
between 110.degree. and 130.degree..
[0027] The central extranasal portion may be substantially rigid.
But this requires parting the nostrils to install the nasal
dilator. That is why in yet other preferred conditions of
embodiment of the invention, the central extranasal portion is made
of a material that is elastic and advantageously ultralight.
[0028] To install the nasal dilator, it is then sufficient to press
laterally on the branches, to insert the nasal side walls between
the U-shaped end branches and to release the pressure. The
elasticity of the central extranasal portion parts the alas of the
nose by spring effect and the pressure plates, in the articulated
version, closely follow the shapes of the intranasal skin.
[0029] On the other hand, in U.S. Pat. No. 1,034,123 whose central
extranasal portion pinches the nasal ridge, because the central
branches of the U are brought closer together and because of the
elasticity of said central extranasal portion, it is necessary
first not to press but to part the branches laterally in the
central extranasal portion, then secondly release them to attach,
by pinching, the device to the nose, then squeeze up the distal
portions of the branches to fourthly insert them into the entrance
of the nostrils, in order fifthly and finally to release them.
[0030] In the nasal dilator that is the subject of the present
invention, the central extranasal portion is in the middle of the
central extranasal portion against the nasal ridge, unlike
Nozovent.RTM. whose most comparable portion is situated under the
nose.
[0031] In yet other preferred conditions of embodiment of the
invention, the frame is made of a shape-memory metal alloy (a
nonpolymer) that is advantageously biocompatible such as
nickel-titanium (NiTi) or titanium-molybdenum (TiMo). The frame
particularly has the shape of a metal alloy wire or cable.
[0032] The mechanical qualities of titanium alloys make it possible
to produce a very thin and light frame. Titanium-molybdenum and/or
nickel-titanium have a very high superelasticity which renders the
device of the invention truly reusable. TiMo or NiTi allow easy
management of the forces exerted via their degree of flexibility
that can be varied at will. They also make it possible to vary the
cross section of the frame (for example from 0.5 to 2 mm) according
to the various zones of the device (central portion, curves, etc.).
So the forces exerted at different degrees of flexing of the device
(according to the variable dimensions of noses) on the alas of the
nose may remain relatively constant. Three different sizes of the
device of the invention may however satisfy the anatomic variations
of the nose in individuals.
[0033] The frame is advantageously covered at least partly with a
biocompatible material such as a preferably surgical category
silicone.
[0034] In yet other preferred conditions of embodiment of the
invention, the pressure plates are used or arranged to deliver an
active ingredient associated or juxtaposed with said pressure
plates.
[0035] For this it is possible to use impregnated pressure plates
or cover the surface of the plates in contact with the intranasal
skin with the aid of such an active ingredient where necessary
associated with a base, particularly an adhesive base.
[0036] It is possible where necessary to deposit a small quantity
of gel for example containing xylocaine in addition to lubricating
components on the surface of the plates in contact with the
intranasal skin to reduce possible irritation and anesthetize the
effect of the initial pressure. The lubricant will preferably be an
antisnoring oil.
[0037] The pressure plates may release medicinal products with a
volatile base contained between the frame and the silicone
envelope. Each flexion of the device may cause the medicinal
product to flow. The medicinal product advantageously has a boiling
point lower than the temperature of the nasal cavity, particularly
lying between the ambient temperature and the temperature of the
nasal cavity. The vaporization of the product will thus be limited
to the periods of use.
[0038] The progressive intranasal medicinal release has certain
advantages relative to the sprays and other actions that are not
sustained over time and allows a constant local concentration of
products without an initial peak. The absorbent qualities of the
nasal mucus and the possibility of a very progressive and
continuous release, including during sleep, open up an alternative
route to all sorts of therapies.
[0039] The combination of features that defines the nasal dilator
that is the subject of the present invention confers very
worthwhile properties on the latter. The two ends of the dilator,
placed against the inner face of the nasal side walls, part the
latter by spring effect, cause a reversible widening of the
anterior nasal cavity and prevent the collapse of the nasal side
walls during inspiration. Consequently, the nasal dilator that is
the subject of the present invention improves breathing by reducing
nasal respiratory resistance and increasing the air flow through
the nasal cavities.
[0040] The considerable increase in the intranasal cross section
reduces the speed of the inspired air while increasing the flow of
inspired air, thus minimizing turbulent flow and snoring.
[0041] An original feature of the nasal dilator that is the subject
of the present invention is the installation of its center of
flexion (that is the middle of the central extranasal portion)
above the nostrils and particularly against the nasal ridge, which
creates a reaction force of the nose. The resultant of all the
forces exerted on the device is thus a force tending to cause the
nasal dilator that is the subject of the present invention to enter
the nose. This movement is limited by the web of the U-shaped end
portions since the alas of the nose are sandwiched by this end
portion of the dilator and butt against the web of the U. It does
not pinch the nose and the only pressure it exerts is the parting
of the nostrils. The obstruction it can cause is therefore
limited.
[0042] The device does not require the pressure plates to rub on
the intranasal skin to be effective, which renders the presence of
protuberances unnecessary and makes it possible to cover the
pressure plates with a smooth, well tolerated surface.
[0043] The nasal dilator that is the subject of the present
invention does not require an adhesive to fulfill its function.
However, in certain circumstances, an adhesive may be used to
totally prevent, if desired, the central extranasal portion from
separating from the surface of the nose.
[0044] These properties in particular justify the nasal dilator
described hereinabove being used by all individuals desiring to
increase their nasal breathing to remedy any inadequacy, transient
or constant, both for everyday life and for sport.
[0045] Finally, the object of the present application is the use of
a nasal dilator of the present invention to increase the nasal
breathing of an individual or of a mammal such as a member of the
horse family.
[0046] For this purpose, a mammal, particularly an individual, is
furnished with a nasal dilator of the present invention as
indicated hereinabove.
[0047] The invention will be better understood if reference is made
to the appended drawings in which
[0048] FIG. 1 represents a view in perspective of a nasal
dilator
[0049] FIG. 2 represents a view in profile of a nasal dilator
installed on the nose
[0050] FIG. 3 represents a front view of a nasal dilator of the
invention.
[0051] FIG. 1 shows that the nasal dilator comprises a frame that
is in the form of a wire comprising seven bends. This frame may be
subdivided into three portions, delimited by XX' and YY'. The frame
of the embodiment shown here forms a continuous line formed of six
straight line segments and five curves.
[0052] The nasal dilator comprises a bent central extranasal
portion 1 (extranasal because, once installed, it will rest on the
outside of the nose) and two intranasal portions 2 and 2'.
[0053] The extranasal portion 1 situated between XX' and YY' is
generally U-shaped, bent into a gentle curve, and comprises a
central portion delimited by two bends 3 and 3' of approximately
120.degree. each followed by a short branch which give thereto a
general shape of a chair seat and back. The extranasal portion is
followed by two other hairpin bends 4, 4' that thus each form a U,
bends from which the two intranasal portions 2 and 2' of the device
begin.
[0054] The two ends 5 and 5' of the two intranasal portions are
progressively narrowed and curved at approximately 90.degree. in
the direction of the other branch of the U. They comprise at their
ends a pressure plate 6 and 6' made of the same material as the
frame. This pressure plate is advantageously covered with a
silicone material.
[0055] The narrowing of the cross section of the frame at this
level 5, 5' creates a multidirectional articulation which allows
the plate to tilt in almost all directions, thereby allowing it to
adapt to the intranasal morphology of its user.
[0056] The curves of the bends 4, 4' closely following the alas of
the nose prevent the pressure plates from accidentally entering
further into the nostrils than intended and prevent the plates from
coming into contact with the deeper and more sensitive nasal mucus.
The pressure plates will therefore always remain beyond the ostium
internum. At the mid-level, the frame of the embodiment shown here
has a diameter greater than that of the other portions of the frame
and is covered with a layer of silicones softening its contact with
the alas of the nose, which it grips lightly to improve retention
of the device.
[0057] In FIG. 2, the device is placed in a functional position on
the nose. The dashed portion represents the most practical manner
of installing the device on the nose. When the plates are pressing
on the intranasal skin, the frame is tilted toward the back of the
head to cause the mid-portion of the frame to rest on the nose. In
this figure, it is not possible to distinguish the intranasal
portions 2 and 2' inserted into the nostrils. On the other hand,
one of the side bends 3 of the extranasal portion 1 and an ala of
the nose sandwiched between the extranasal portion 1 and the
corresponding intranasal portion 2 are clearly distinguishable.
Observe also the abutting position of the bottom of the U-shaped
end branches of the frame, at the curve 4 against the ala of the
nose.
[0058] In FIG. 3, the drawing in dashed line represents the device
bent in the position for insertion into the nose. For this, all
that is required is to press the device laterally, for example
between the thumb and the index finger. The drawing in solid line
represents the device in the functional position, parting the alas
of the nose, when the user has released the lateral pressure after
having inserted the device into the nose. The angle between the
U-shaped branches of the mid-portion 1 at rest is approximately
100.degree. as can be seen.
[0059] It is again possible to see in this figure practically all
the elements of FIG. 1, except for the bends 2 and 2' supported by
the extranasal portion and the extranasal portion lying between the
bends 3, 3' and 4, 4'.
[0060] Producing a nasal dilator of the invention in one piece,
simply fully covered with a layer of silicones, makes its
industrial manufacture easier.
[0061] A greater thickness of the layer of silicones on certain
zones such as the pressure plates, the mid-portion or certain
curves makes them soft.
[0062] The mid-portion of the extranasal segment 1 of the device
may, if necessary, be provided with an adhesive surface for
intensive sporting use. However, preference goes to a nonadhesive
mid-portion, attached with the aid of double-sided adhesive tape,
independent of the device.
[0063] The average size of the device is preferably as follows, for
a frame made of TiMo or NiTi with an average diameter of 1 mm,
designed for an adult man of 1.80 m:
TABLE-US-00001 Length between the mid-portion and the 3 cm bend 3,
3' Length between the bend 3, 3' and the 2 cm bend 4, 4' Gap
between the U-shaped end branches 1 cm 4, 4' Length of an
intranasal portion 1 cm Diameter of circular-shaped pressure 8 mm
plates Thickness of pressure plates 1 mm Angle between the U-shaped
branches of 100.degree. the mid-portion
* * * * *